Drug Rescue

Through our CardioSafe 3D and LiverSafe 3D drug rescue programs, we believe we can recapture substantial value from the prior investment by pharmaceutical companies and others who have developed and established the efficacy potential of still-promising new drug candidates that have been terminated prior to FDA approval due to heart or liver safety concerns. Using CardioSafe 3D and, eventually, LiverSafe 3D, together with medicinal chemistry, we are focused on generating proprietary new chemical entities (NCEs) for our internal development pipeline. We believe focusing solely on drug rescue opportunities involving drug candidates in the public domain and previously optimized for efficacy by pharmaceutical companies and others offers us a valuable “head start advantage” in our efforts to produce NCEs for our internal pipeline faster and less expensively than drug candidates discovered and developed using only conventional in vitro assays and live animal models.

Strategic Partners

Successful partnerships are critical to the achievement of our strategic objectives. Developing and nurturing long term research and business collaborations have enabled us to strengthen our core competencies and develop new skills as the biopharmaceutical industry continues to grow at an exciting pace. We seek strategic collaborations wherever there is a tight fit between our assets and skills and the potential for leveraging the capabilities and technologies of partners to enable joint success. We are open to diverse collaboration models framed around mutually beneficial commercial and research and development opportunities.

We seek to partner proactively with like-minded research teams and companies, with the goal of creating a vibrant, effective and innovative drug development and drug recue ecosystem to drive our programs towards new therapeutic modalities, cost effectively and efficiently. We welcome strategic partnering requests, technology licensing offers or other collaborative proposals from the research and business communities at large.

Cato Research is a global contract research organization (CRO) that offers a wide range of integrated services to pharmaceutical, biotechnology, and medical device companies. They specialize in complex development programs requiring innovative regulatory and clinical strategies, and have experience implementing and conducting successful clinical trials and development programs. Cato Research provides us regulatory and drug development expertise for our AV-101 development programs and also acts as a source of potential drug rescue candidates and strategic collaborations.

The Centre for Commercialization of Regenerative Medicine (CCRM) is a Canadian, not-for-profit organization supporting the development of foundational technologies that accelerate the commercialization of stem cell- and biomaterials-based products and therapies. CCRM is supported by the Centres of Excellence for Commercialization and Research (CECR) Program. CCRM brings together leading RM experts from the University of Toronto and McMaster University, with researchers from the Hospital for Sick Children, the University Heath Network, the Ottawa Hospital Research Institute and Mount Sinai Hospital, to accelerate Regenerative Medicine (RM) research and development, and create a commercialization pipeline that rapidly brings RM technologies to market. These researchers are working to harness the power of stem cells, biomaterials and molecules through innovative technologies to treat, and perhaps cure, diseased cells, tissues and organs.

The McEwen Centre for Regenerative Medicine’s mission is to be a catalyst for regenerative medicine by facilitating collaboration, supporting research, and promoting awareness of the field. The Centre includes 15 scientists at five Toronto hospitals, as well as the University of Toronto. Currently, these scientists are working to accelerate the development of more effective treatments for conditions such as heart disease, diabetes, respiratory disease and spinal cord injury. The McEwen Centre is supported by philanthropic contributions and research grants, and is based at University Health Network in Toronto, Canada. They also collaborate with many other research institutions throughout North America, Europe and the Asia/Pacific region.

Internationally regarded for its dedication to medical science, Mount Sinai is home to an array of leading research institutes, centers, and laboratories, all of which work toward rapidly translating advances in basic science into innovative patient care. With a history rich in clinical milestones and an unequaled passion for patient-focused research, Mount Sinai has pioneered breakthroughs benefiting untold numbers of lives.

National Jewish Health is known worldwide for treatment of patients with respiratory, cardiac, immune and related disorders, and for groundbreaking medical research. Founded in 1899 as a nonprofit hospital, National Jewish Health remains the only facility in the world dedicated exclusively to these disorders. Since 1998, U.S. News & World Report has ranked National Jewish Health the #1 respiratory hospital in the nation. NJH maintains a proactive approach to medicine, with its research focusing on environment-gene interaction and making strides in predicting, preventing, treating and tracking many diseases. Our research is truly transforming the lives of millions. By using an individual’s DNA to predict and prevent disease, to guide the right choice of therapy to limit side effects and bring higher success rates for treatments and to be able to track the effects of these therapies, National Jewish Health is working to improve healthcare for the future.

The largest source of funding for medical research in the world, the U.S. National Institutes of Health (NIH) is made up of 27 institutes and centers. For over a century, NIH scientists have paved the way for important discoveries that improve health and save lives. The medical research agency has created hundreds of thousands of high-quality jobs by funding thousands of scientists in universities and research institutions in every state across America and around the globe. Through February 2015, VistaGen has been awarded over $8.8 million from NIH for preclinical and Phase 1 development of AV-101. In February 2015, VistaGen and the NIH entered into a Cooperative Research and Development Agreement (CRADA). Under the CRADA, the U.S. National Institute of Mental Health (NIMH), part of the NIH, will conduct and fully-fund a Phase 2 efficacy and safety study of AV-101 in Major Depressive Disorder.

The U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH), is the largest scientific organization in the world dedicated to mental health research. NIMH is one of 27 Institutes and Centers of the NIH, the world’s leading biomedical research organization. The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit www.nimh.nih.gov.

Synterys, Inc. is a San Francisco Bay Area medicinal chemistry and collaborative drug discovery provider focused on the needs of virtual and small drug discovery companies. They are headquartered in the US with fully modern overseas facilities in Taiwan. With an internal focus on high-quality synthetic organic medicinal chemistry, they are virtually integrated with outstanding computational chemistry, DMPK and manufacturing partners to provide all the tools necessary for the rapid advancement of discovery projects. The company’s highly experienced senior management team and staff have multiple years of experience in large pharmaceutical and small biotech companies and a proven track record of drug discovery success with numerous clinical candidates invented.

Providing care to the community for more than 200 years, UHN is a major landmark in Canada’s healthcare system and a teaching hospital of the University of Toronto. Building on the strengths and reputation of each of the three hospitals, Princess Margaret Hospital, Toronto General Hospital, and Toronto Western Hospital, UHN brings together the talent and resources needed to achieve global impact and provide exemplary patient care, research and education. Approximately 2,700 scientists, technical staff, students and trainees at University Health Network are working together to solve fundamental and applied research problems, with much of the research focused on four priority platforms: Genes, Proteins, and People; Medical Technology Innovation; Health Informatics; and Regenerative Medicine.